Skip to main content

Warning message

Engineering Systems Specialist

OBJECTIVES/PURPOSE

The Engineering System Specialist is integrated in the Engineering Systems team. The scope of this position is to:

  • Create and improve the templates of engineering documentation including validation documentation
  • Create and improve engineering guidance to standardize the flow of the documentation and the validation requirements
  • Coordinate and Improve the structure engineering documentation repertory.
  • Coach partners of the engineering team to improve their documentation aspect
  • Write/Review project documentation drafted by engineers before the official validation review
  • Support engineering team for new projects according to GMP and Best Engineering Practices requirements.
  • Scope of the function:

  • Filling,and Packing Engineering and automation.
  • Purification / Utilities Engineering and automation.
  • HVAC and Facilities Engineering and automation.
  • ACCOUNTABILITIES

  • The incumbent is a validation expert supporting mechanical and automation engineering projects documentations (URS, Functionnal & design specifications, commissioning activities…)
  • Create and improve templates & guidances for Site Engineering activities (tenders, validation packages, ...)
  • Support the redaction, coach engineers and review of documentations before Validation Agreement.
  • Recommend efficient improvement to qualify equipments and systems.
  • Coordinate engineering documentation activities to support the projects
  • Improve the department documentation structure.
  • Periodic review of Engineering procedures and forms to ensure alignment with local/divisional procedures
  • Assure strict compliance with cGMP, 21 CFRs, GAMP5, Corporate, Divisional and regulatory requirements
  • Support site activities as a technical professional to facilitate investigations
  • DIMENSIONS AND ASPECTS

    Technical/Functional (Line) Expertise

    He or She is able to understand all technical installations, equipments and sytems used on the site.He or She is comfortable with the main requirement of validation for a new system or equipment. He or She is comfortable with technical documentation, engineering aspects, protocols and quality documentation to support all activities on site. He or She is perfectly aware of current validation divisional procedure.

    Leadership

    He or she is also able to be factual to report problematics to management.

    He or She is able to analyse the current process and identify the improvements to do to simplify and standardize.

    Decision-making and Autonomy

    He or She is able to report his or her final evaluation of technical choices inside projects core team. He or She will present this final evaluation to a final review for coaching by the manager or the senior engineer before presenting the final statement for agreement at the superior management level.

    Interaction

    He or She is a collaborative and proactiv member inside a team. He or She is sensitive and highly consider humans problematics to interact with other departments with demonstrated communication skills.

    Innovation

    Leads benchmark and innovative ideas, propose innovation long term plan.

    Complexity

    He or She have to take as a main priority EHS aspects inside all interventions on line.

    He or She is aware of the complexity of products manufactured by TAKEDA Lessines, the complexity of aseptics aspects. He or She is also able to understand humans challenge complexity, to be able to respect any interlocutors by applying TAKEDA ethics code.

    EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

    Engineering Systems Specialist

    Biolife Plasma, Lessines
    Categories: 
    Engineer
    Degree Level: 
    Master
    Apply before: